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Phase 2 randomized double blind controlled study to investigate disease modifying effect, safety and optimal dose of oral semaglutide tablet for patients with Parkinson's disease (MOST-ABLE study)

Phase 2 study of oral semaglutide tablet for patients with Parkinson's disease

Kimura Yasuyoshi

The University of Osaka Hospital

2-15 Yamadaoka, Suita, Osaka

y-kimura@neurol.med.osaka-u.ac.jp

Koda Toru

The University of Osaka Hospital

2-2 Yamadaoka, Suita, Osaka

+81-6-6210-8290

toru.koda@dmi.med.osaka-u.ac.jp

Not Recruiting

Nov. 06, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Aged 20-80 years at the time of informed consent
2) Diagnosed with PD by a neurologist [In terms of diagnosis, meet the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (UKPDSBB criteria) International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic criteria (MDS-PD criteria, clinically established PD) or MDS-early PD criteria]
3) On-time Modified Hoehn and Yahr classification <=2.5
4) Receiving stable PD medication for 4 weeks prior to V1. For MAO-B inhibitors, stable dose and dosage for 12 weeks prior to V1.
5) With written informed consent

1) Diagnosed or supected with Parkinson's syndrome other than PD
2) Familial PD
3) Showing abnormalities with brain MRI or CT that may affect DaTscan results
4) Cannot come to the hospital in an off-state
5) Moderate-severe depression with PHQ-9>=16
6) Cognitive dysfunction with MMSE<=23 or FAB<=11
7) Receiving device aided therapy, previous history of irreversible brain surgery, previous history of gene therapy or cell transplantation as PD treatment
8) Currently participating in another investigational study and previously participated in investigational study of disease-modifying therapies
9) Body mass index<18.5
10) Type1 or Type2 diabetes mellitus
11) Severe gastrointestinal disorder, severe Gastro esophageal reflux disease and previous history of gastrectomy
12) Previous history of Pancreatitis
13) Kidney dysfunction with eGFR<30mL/min
14) Decompensated cirrhosis
15) Diagnosed or supected Thyroid tumor
16) Previous history or family history of Multiple endocrine neoplasia type2
17) Pregnant, breastfeeding and unable to contraception during the study period
18) Receiving medication to be taken upon waking and unable to change or discontinue during the study period
19) Eat, drink, or take oral medication within 8 hours prior to taking the study drug
20) Previous use of GLP-1 receptor agonists, including semaglutide
21) Answer "yes" to item 4 or item 5 of the C-SSRS suicidal ideation. Current or past suicidal behavior or received treatment for suicidal attempts or plans
22) Unable to DaTscan due to alcohol sensitivity
23) Other, unqualified for this study decided by investigator

Both

Parkinson's disease

Semaglutide 7mg group; semaglutide 3mg once daily for 4weeks, then 7mg once daily for 32weeks
Semaglutide 14mg group; semaglutide 3mg once daily for 4weeks, then 7mg once daily for 4weeks, then 14mg once daily for 28weeks
placebo group; once daily for 36weeks

D010300

Change in clinically defined off-state MDS-UPDRS part 3 score at 48week

Safety and tolerability of semaglutide
- Changes in the clinically defined off-state MDS-UPDRS part 3 score at 36 weeks
- Changes in the MDS-UPDRS parts 1,2,3, and 4 scores in the ON medication state at 36 weeks
- Changes in the MDS-UPDRS parts 1,2,3, and 4 scores in the ON medication state at 48 weeks
- Change in the Japanese version of the Parkinson's Disease Questionnaires-39 (J-PDQ-39) score at 36 and 48 weeks
- Change in the Montreal Cognitive Assessment-Japanese (MoCA-J) score, Symbol Digit Modality Test (SDMT) score, Digit Span score, noise pareidolia test (NPT) score, and Japanese version of the Patient Health Questionnaire-9 (J-PHQ-9) at 48 weeks
- Patient Global Impression Change score at 36 and 48 weeks
- Quantitative change in Dopamine Transporter availability at 48 weeks
- Levodopa Equivalent Daily Dose

+81-6-6210-8290

Oct. 11, 2022

Yes

Following the publication of primary results, sharing of anonymized IPD will be permitted only for applications approved by the trial coordinating physician as having academic merit and ethical validity.

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